WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX; NAIL, FIXATION, BONE
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Model Number 04.004.000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that on (b)(6) 2021 the patient underwent the removal of one (1) titanium cannulated tibial nail, two (2) unknown dual-core screws, twelve (12) unknown locking screws, one (1) ti end cap and one (1) tomofix p tibial head plate due infection.The procedure was successfully completed.The patient outcome is unknown.This report is for one (1) ti end cap with t40 stardrive 0mm ext f/ti tibial nails-ex.This is report 3 of 10 for (b)(4).This report is linked to (b)(4).
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Search Alerts/Recalls
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